BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM RECLAIM DISTAL STEM

    MDR report key: 18213084 · Received November 27, 2023

    Report

    Report Number
    1818910-2023-24047
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    January 1, 2023
    Report Date
    November 27, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.  IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. B3: DATE OF EVENT IS AN UNKNOWN DATE. H6: COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: VASIREDDI N, NEITZKE CC, CHANDI SK, CORORATON AD, DRISCOLL DA, SCULCO PK, CHALMERS BP, GAUSDEN EB. EARLY PERIPROSTHETIC FEMUR FRACTURES AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY: HIGH RISK OF PERIPROSTHETIC JOINT INFECTION AND SUBSEQUENT REOPERATION. J ARTHROPLASTY. 2023 OCT 21:S0883-5403(23)01083-5. DOI: 10.1016/J.ARTH.2023.10.037. EPUB AHEAD OF PRINT. PMID: 37871864. OBJECTIVE AND METHODS: THE OBJECTIVE OF THIS STUDY WAS TO COMPARE RATES OF PERIPROSTHETIC JOINT INFECTION (PJI) AND REOPERATION FOLLOWING PERIPROSTHETIC FEMUR FRACTURES (PFFS) THAT OCCURRED EARLY POSTOPERATIVELY TO THOSE THAT OCCURRED LATE. AUTHORS RETROSPECTIVELY IDENTIFIED 173 CONSECUTIVE, SURGICALLY MANAGED PFFS FOLLOWING PRIMARY THA. CASES WERE CATEGORIZED AS ¿EARLY¿ IF THEY OCCURRED WITHIN 90 DAYS OF THA (N=117) OR ¿LATE¿ IF THEY OCCURRED FOLLOWING THE INITIAL 90 DAYS (N=56). MEAN FOLLOW-UP WAS 2 YEARS (RANGE, 0 TO 13 YEARS). KAPLAN MEIER SURVIVAL ANALYSIS ESTIMATED CUMULATIVE INCIDENCES OF PJI AND REOPERATION. THE STUDY INCLUDED 9 DIFFERENT IMPLANT MANUFACTURERS ENCOMPASSING 21 DIFFERENT MODELS OF FEMORAL STEMS FOR PRIMARY TOTAL HIP ARTHROPLASTIES¿DEPUY WAS REPRESENTED BY CORAIL (3 EARLY STEM FRACTURES/0 LATE STEM FRACTURES), TRILOCK BPS (2 EARLY STEM FRACTURES/0 LATE STEM FRACTURES), SUMMIT DUOFIX HA COATED (6 EARLY STEM FRACTURES/2 LATE STEM FRACTURES), AND ACTIS-COLLARED (1 EARLY STEM FRACTURES/0 LATE STEM FRACTURES). FOR TREATMENT OF THE PPFS, 7 MANUFACTURERS WERE UTILIZED ENCOMPASSING 13 MODELS, OF WHICH DEPUY WAS REPRESENTED BY RECLAIM (1 EARLY STEM FRACTURES/0 LATE STEM FRACTURES) AND TRILOCK BPS (1 EARLY STEM FRACTURES/0 LATE STEM FRACTURES). THE AUTHORS PROVIDED NO ADDITIONAL PRODUCT DETAILS, SUCH AS ACETABULAR CONSTRUCT MANUFACTURERS OR PRODUCTS, BEARING SURFACE TYPES, OR PRODUCT/LOT CODE INFORMATION. PATIENTS WERE NOT BROKEN DOWN BY CASE NUMBER OR AGE/GENDER DEMOGRAPHICS. RESULTS: EARLY PFFS HAD HIGHER 2-YEAR CUMULATIVE INCIDENCE OF PJI (11% VERSUS 0%) AND REOPERATION (24% VERSUS 13%). FOLLOWING EARLY PFF, 27 PATIENTS REQUIRED REOPERATION (I.E., 13 FOR PJI, 5 FOR INSTABILITY, 2 FOR RE-FRACTURE, 2 FOR PAINFUL HARDWARE, 2 FOR NONUNION, 1 FOR ADVERSE LOCAL TISSUE REACTION, 1 FOR ASEPTIC LOOSENING, AND 1 FOR LEG-LENGTH DISCREPANCY). FOLLOWING LATE PFF, 5 PATIENTS REQUIRED REOPERATION (I.E., 3 FOR INSTABILITY, 1 FOR RE-FRACTURE, AND 1 FOR NONUNION). ADDITIONALLY, AFTER PFF FIXATION, THERE WERE 85 PATIENTS WHO REQUIRED BLOOD TRANSFUSION (57 (49%)) FOLLOWING EARLY PFF AND 28 (50%) FOLLOWING LATE PFF), 5 PATIENTS WHO DEVELOPED POSTOPERATIVE URINARY RETENTION, 4 PATIENTS WHO DEVELOPED ILEUS, 3 PATIENTS WHO DEVELOPED DEEP VEIN THROMBOSES, 3 PATIENTS WHO DEVELOPED POSTOPERATIVE DELIRIUM, 2 PATIENTS WHO DEVELOPED URINARY TRACT INFECTIONS, AND 2 PATIENTS WHO DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION WHICH WAS MEDICALLY CONVERTED TO NORMAL SINUS RHYTHM. ONE PATIENT DEVELOPED ACUTE DECOMPENSATED CONGESTIVE HEART FAILURE (CHF) NECESSITATING INTUBATION. ONE PATIENT DEVELOPED POSTOPERATIVE PULMONARY INSUFFICIENCY REQUIRING INTUBATION WITH EPINEPHRINE AND NEOSTIGMINE DRIPS, WHICH WAS COMPLICATED BY VENTILATOR-ASSOCIATED PNEUMONIA AND DEMAND ISCHEMIA IN THE SETTING OF CHF. THERE WAS ONE PATIENT WHO HAD A POSTOPERATIVE CARDIAC ARREST SECONDARY TO TOTAL SPINAL ANESTHESIA, WHICH DID RESULT IN RETURN OF SPONTANEOUS CIRCULATION, BUT WAS COMPLICATED BY ASPIRATION PNEUMONIA. ALSO, ONE PATIENT DEVELOPED AN OBSTRUCTION AT THE ANASTOMOTIC SITE OF A PREVIOUS GASTRIC BYPASS SURGERY. THE AUTHORS STATED THAT THERE WERE TWO DEATHS DURING THE STUDY PERIOD¿ONE WITHIN THE LATE COHORT DIED 11 MONTHS AFTER INITIAL PFF FIXATION, AND ONE WITHIN THE EARLY COHORT DIED 42 MONTHS AFTER INITIAL PFF. AUTHORS DID NOT PROVIDE MANUFACTURERS OF THE PRODUCTS INVOLVED NOR CAUSES OF DEATH. THERE WERE FIFTEEN PATIENTS WHO HAD ONE OR MORE DISLOCATIONS TREATED WITH CLOSED REDUCTION FOLLOWING PFF FIXATION (9%), INCLUDING 8 FOLLOWING LATE PFF AND 7 FOLLOWING EARLY PFF. OF THESE 15 PATIENTS, 8 HAD SUBSEQUENT REOPERATIONS FOR RECURRENT INSTABILITY AS DESCRIBED IN THE REOPERATIONS SECTION. THERE WERE 5 PATIENTS WHO DEVELOPED NONUNION OF THEIR PFF; ONE OF THESE PATIENTS HAD A NONUNION OF THE FEMORAL SHAFT AND UNDERWENT ORIF, WITH PLACEMENT OF A PERIPROSTHETIC LOCKING PLATE WITH CROSS BONY SCREWS IN ADDITION TO DEMINERALIZED BONE MATRIX (AUTOGRAFT). THE REMAINING 4 PATIENTS HAD NONUNION OF THE GREATER TROCHANTER (GT), TWO OF WHICH FAILED FIXATION WITH A TROCHANTERIC CLAW PLATE AFTER THE FRACTURE HAD GT NONUNION DID NOT UNDERGO FURTHER FIXATION. ONE PATIENT DEVELOPED POSTOPERATIVE SCIATIC NEUROPRAXIA AFTER PFF FIXATION. ADDITIONALLY, AFTER PFF FIXATION, THERE WERE 85 PATIENTS WHO REQUIRED BLOOD TRANSFUSION (57 (49%) FOLLOWING EARLY PFF AND 28 (50%) FOLLOWING LATE PFF), 5 PATIENTS WHO DEVELOPED POSTOPERATIVE URINARY RETENTION, 4 PATIENTS WHO DEVELOPED ILEUS, 3 PATIENTS WHO DEVELOPED DEEP VEIN THROMBOSES, 3 PATIENTS WHO DEVELOPED POSTOPERATIVE DELIRIUM, 2 PATIENTS WHO DEVELOPED URINARY TRACT INFECTIONS, AND 2 PATIENTS WHO DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION WHICH WAS MEDICALLY CONVERTED TO NORMAL SINUS RHYTHM. ONE PATIENT DEVELOPED ACUTE DECOMPENSATED CONGESTIVE HEART FAILURE (CHF) NECESSITATING INTUBATION. ONE PATIENT DEVELOPED POSTOPERATIVE PULMONARY INSUFFICIENCY REQUIRING INTUBATION WITH EPINEPHRINE AND NEOSTIGMINE DRIPS, WHICH WAS COMPLICATED BY VENTILATOR-ASSOCIATED PNEUMONIA AND DEMAND ISCHEMIA IN THE SETTING OF CHF. THERE WAS ONE PATIENT WHO HAD A POSTOPERATIVE CARDIAC ARREST SECONDARY TO TOTAL SPINAL ANESTHESIA, WHICH DID RESULT IN RETURN OF SPONTANEOUS CIRCULATION, BUT WAS COMPLICATED BY ASPIRATION PNEUMONIA. ALSO, ONE PATIENT DEVELOPED AN OBSTRUCTION AT THE ANASTOMOTIC SITE OF A PREVIOUS GASTRIC BYPASS SURGERY. CONCLUSION: THERE ARE GREATER INCIDENCES OF PJIS AND OVERALL REOPERATIONS FOLLOWING EARLY PFFS COMPARED TO LATE PFFS AFTER THA. IN ADDITION TO FOCUSING EFFORTS ON PREVENTION OF EARLY PFFS, SURGEONS SHOULD CONSIDER ANTISEPTIC INTERVENTIONS TO MITIGATE THE INCREASED RISK OF PJI AFTER TREATMENT OF EARLY PFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239263 UNK HIP FEMORAL STEM RECLAIM DISTAL STEM FEMORAL STEM LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention